Methods of obtaining ophthalmic lenses providing the eye with reduced aberrations

ABSTRACT

The present invention discloses methods of obtaining ophthalmic lens capable of reducing the aberrations of the eye comprising the steps of characterizing at least one corneal surface as a mathematical model, calculating the resulting aberrations of said corneal surface(s) by employing said mathematical model, selecting the optical power of the intraocular lens. From this information, an ophthalmic lens is modeled so a wavefront arriving from an optical system comprising said lens and corneal model obtains reduced aberrations in the eye. Also disclosed are ophthalmic lenses as obtained by the methods which are capable reducing aberrations of the eye.

RELATED APPLICATIONS

The present application is a divisional application of U.S. applicationSer. No. 10/606,910, filed Jun. 26, 2003, which is a divisionalapplication of U.S. application Ser. No. 091863,546, filed May 23, 2001.

FIELD OF INVENTION

The present invention relates to methods of designing ophthalmic lensesthat provide the eye with reduced aberrations, as well as lenses capableof providing such visual improvements.

BACKGROUND OF THE INVENTION

It is presently discussed that the visual quality of eyes having animplanted intraocular lens (IOL) is comparable with normal eyes in apopulation of the same age. Consequently, a 70 year old cataract patientcan only expect to obtain the visual quality of a non-cataracteousperson of the same age after surgical implantation of an intraocularlens, although such lenses objectively have been regarded as opticallysuperior to the natural crystalline lens. This result is likely to beexplained by the fact that present IOLs are not adapted to compensatefor defects of the optical system of the human eye, namely opticalaberrations. Age-related defects of the eye have recently beeninvestigated and it is found that contrast sensitivity significantlydeclines in subjects older than 50 years. These results seem to complywith the above-mentioned discussion, since the contrast sensitivitymeasurements indicate that individuals having undergone cataract surgerywith lens implantation lens will not obtain a better contrastsensitivity than non-cataracteous persons of an average age of about 60to 70 years.

Even if intraocular lenses aimed at substituting the defective cataractlens and other ophthalmic lenses, such as conventional contact lenses,have been developed with excellent optical quality as isolated elements,it is obvious that they fail to correct for a number of aberrationphenomena of the eye including age-related aberration defects.

U.S. Pat. No. 5,777,719 (Williams et al.) discloses a method and anapparatus for accurately measuring higher order aberrations of the eyeas an optical system with wavefront analysis. By using a Hartmann-Shackwavefront sensor, it is possible to measure higher order aberrations ofthe eye and use such data to find compensation for these aberrations andthereby obtain sufficient information for the design of an optical lens,which can provide a highly Improved optical performance. TheHartmann-Shack sensor provides means for analyzing light reflected froma point on the retina of the eye of a subject. The wavefront in theplane of the pupil is recreated in the plane of the lenslet array of theHartmann-Shack sensor. Each lenslet in the array is used to form anaerial image of the retinal point source on a CCD camera located at thefocal plane of the array. The wave aberration of the eye, in the formresulting from a point source produced on the retina by a laser beam,displaces each spot by an amount proportional to the local slope of thewavefront at each of the lenslets. The output from the CCD camera issent to a computer, which then performs calculations to fit slope datato the first derivatives of 66 Zernike polynomials. From thesecalculations, coefficients for weighting the Zernike polynomials areobtained. The sum of the weighted Zernike polynomials represents areconstructed wavefront distorted by the aberrations of the eye as anoptical system. The individual Zernike polynomial terms will thenrepresent different modes of aberration.

U.S. Pat. No. 5,050,981 (Roffman) discloses another method for designinga lens by calculating modulation transfer functions from tracing a largenumber of rays through the lens-eye system and evaluating thedistribution density of the rays in the image position. This isrepeatedly performed by varying at least one lens surface until a lensis found which results in a sharp focus and a maximum modulationtransfer function.

U.S. Pat. No. 6,224,211 (Gordon) describes a method of improving thevisual acuity of the human eye by successively fitting aspheric lensesto the cornea and thereby finding a lens that can reduce sphericalaberration of the whole individual eye.

The methods referred to above for designing are suitable for the designof contact lenses or other correction lenses for the phakic eye whichcan be perfected to compensate for the aberration of the whole eyesystem. However, to provide improved intraocular lenses aimed to replacethe natural crystalline lens, it would be necessary to consider theaberrations of the individual parts of the eye.

U.S. Pat. No. 6,050,687 (Bille et al) refers to a method wherein therefractive properties of the eye are measured and wherein considerationis taken to the contribution of the individual surfaces of the eye tothe total wavefront aberrations. The method described hereinparticularly aims at analyzing the topography of the posterior cornealsurface in order to improve refractive correction techniques.

There has recently been a focus on studying the aberrations of the eye,including a number of studies of the development of these aberrations asa function of age. In two particular studies, the development of thecomponents of the eye were examined separately, leading to theconclusion that the optical aberrations of the individual components ofyounger eyes cancel each other out, see Optical Letters, 1998, Vol.23(21), pp. 1713-1715 and IOVS, 2000, Vol. 41(4), 545. The article of S.Patel et al in Refractive & Corneal Surgery, 1993, Vol. 9, pages 173-181discloses the asphericity of posterior corneal surfaces. It is suggestedthat the corneal data can be used together with other ocular parametersto predict the power and the asphericity of an intraocular lens with thepurpose of maximizing the optical performances of the futurepseudophakic eye. Furthermore, it was also recently observed by AntonioGuirao and Pablo Artal in IOVS, 1999, Vol. 40(4), S535 that the shape ofthe cornea changes with age and becomes more spherical. These studiesindicate that the cornea in the subjects provides a positive sphericalaberration, which increases slightly with the age. On the other hand,the rotationally symmetric aberration of the anterior corneal surfacedoes not seem to be different between younger and older eye according toresults found by T Oshika et al in Investigative Ophthalmology andVisual Science, 1999, Vol. 40, pp. 1351-1355. In Vision Research, 1998,38(2), pp. 209-229, A Glasser et al. investigated the sphericalaberration of natural crystalline lenses from eyes obtained from an eyebank after the cornea has been removed. According to the laser scanneroptical method used herein it was found that the spherical aberrationfrom an older lens (66 years) shows positive spherical aberration,whereas a 10-year-old lens shows negative spherical aberration. Inaddition, Vision Research, 2001, 41, pp. 235-243 (G Smith et al)discloses that the natural crystalline lens appears to have negativespherical aberration when in the relaxed state. Smith et al suggest thatbecause older eyes have a larger aberration, it is likely that thespherical aberration of the crystalline lens becomes less negative withage.

In Ophthal. Physiol. Opt., 1991, Vol. 11, pp. 137-143 (DA Atchison) itis discussed how to reduce spherical aberrations in intraocular lensesby aspherizing the lens surface. The methods outlined by Atchison arebased on geometric transferring calculations, which do not considerdiffraction effects and any variations in refractive index along the raypath in inhomogeneous elements. These calculations will lead to errorsclose to the diffraction limit. Also in WO 98/31299 (Technomed) a raytracing method is outlined according to which the refraction of thecornea is attempted to be considered for the design of an intraocularlens.In view of the foregoing, it is apparent that there is a need forophthalmic lenses that are better adapted or compensated to theaberrations of the individual surfaces of the eye and are capable ofbetter correcting aberrations other than defocus and astigmatism, asprovided by conventional ophthalmic lenses.

DESCRIPTION OF THE INVENTION

It is an object of the invention to provide for methods that result inobtaining an ophthalmic lens, which provides the eye with reducedaberrations,

It is another object of the invention to provide methods of obtaining anintraocular lens capable of reducing the aberration of the eye after itsimplantation into the eye.

It is a further object to provide for methods of obtaining anintraocular lens capable of compensating the aberrations resulting fromoptical irregularities in the corneal surfaces.

It is a still furtier object of the present invention to provide anintraocular lens which is capable of restoring a wavefront deviatingfrom sphericity into a substantially more spherical wavefront.

It is a also an object of the present invention to provide anintraocular lens which is capable of correcting for mean opticalirregularities and imperfections found in a particular group of peopleand thereby provide a lens with improved optical performance for anindividual belonging to the same group.

The present invention generally relates to an ophthalmic lens and tomethods of obtaining said ophthalmic lens that is capable of reducingthe aberrations of the eye. By aberrations in this context is meantwavefront aberrations. This is based on the understanding that aconverging wavefront must be perfectly spherical to form a point image,i.e. if a perfect image shall be formed on the retina of the eye, thewavefront having passed the optical surfaces of the eye, such as thecornea and a natural or artificial lens, must be perfectly spherical. Anaberrated image will be formed if the wavefront deviates from beingspherical. In this context the term nonspherical surface will refer torotationally symmetric, asymmetric and/or irregular surfaces, i.e. allsurfaces differing from a sphere. The wavefront aberrations can beexpressed in mathematical terms in accordance with different approximatemodels as is explained in textbook references, such as M.R. Freeman,Optics, Tenth Edition, 1990.

In a first embodiment, the present invention is directed to a method ofdesigning an intraocular lens capable of reducing aberrations of the eyeafter its implantation. The method comprises a first step ofcharacterizing at least one corneal surface as a mathematical model andby employing the mathematical model calculating the resultingaberrations of the corneal surface. An expression of the cornealaberrations is thereby obtained, i.e. the wavefront aberrations of aspherical wavefront having passed such a corneal surface. Dependent onthe selected mathematical model different routes to calculate thecorneal aberrations can be taken. Preferably, the corneal surface ischaracterized as a mathematical model in terms of a conoid of rotationor in terms of polynomials or a combination thereof. More preferably,the corneal surface is characterized in terms of a linear combination ofpolynomials. The second step of the method is to select the power of theintraocular lens, which is done according to conventional methods forthe specific need of optical correction of the eye, for example themethod described in U.S. Pat. No. 5,968,095 From the information ofsteps one and two an intraocular lens is modeled, such that a wavefrontfrom an optical system comprising said lens and corneal model obtainsreduced aberrations. The optical system considered when modeling thelens typically includes the cornea and said lens, but in the specificcase it can also include other optical elements including the lenses ofspectacles, or an artificial correction lens, such as a contact lens, acorneal inlay implant or an implantable correction lens depending on theindividual situation.

Modeling the lens involves selection of one or several lens parametersin a system which contributes to determine the lens shape of a given,pre-selected refractive power, This typically involves the selection ofthe anterior radius and surface shape, posterior radius and surfaceshape, the lens thickness and the refractive index of the lens. Inpractical terms, the lens modeling can be performed with data based on aconventional spherical lens, such as the CeeOn® lenses from PharmaciaCorp., as exemplified with the CeeOn® Edge (Model 911). In such a case,it is preferred to deviate as little as possible from an alreadyclinically approved model. For this reason, it may be preferred tomaintain pre-determined values of the central radii of the lens, itsthickness and refractive index, while selecting a different shape of theanterior and/or posterior surface, thus providing one or both of thesesurfaces to have an nonspherical shape. According to an alternative ofthe inventive method, the spherical anterior surface of the conventionalstarting lens is modeled by selecting a suitable aspheric component.Preferably the lens has at least one surface described as a nonsphere orother conoid of rotation. Designing nonspherical surfaces of lenses is awell-known technique and can be performed according to differentprinciples and the description of such surfaces is explained in moredetail in our parallel Swedish Patent Application 0000611-4 to which isgiven reference.

The inventive method can be further developed by comparing wavefrontaberrations of an optical system comprising the lens and the model ofthe average cornea with the wavefront aberrations of the average corneaand evaluating if a sufficient reduction in wavefront aberrations isobtained. Suitable variable parameters are found among theabove-mentioned physical parameters of the lens, which can be altered soas to find a lens model, which deviates sufficiently from being aspherical lens to compensate for the corneal aberrations.

The characterization of at least one corneal surface as a mathematicalmodel and thereby establishing a corneal model expressing the cornealwavefront aberrations is preferably performed by direct corneal surfacemeasurements according to well-known topographical measurement methodswhich serve to express the surface irregularities of the cornea in aquantifiable model that can be used with the inventive method. Cornealmeasurements for this purpose can be performed by the ORBSCAN®videokeratograph, as available from Orbtech, or by corneal topographymethods, such as EyeSys® from Premier Laser Systems. Preferably, atleast the front corneal surface is measured and more preferably bothfront and rear corneal surfaces are measured and characterized andexpressed together in resulting wavefront aberration terms, such as alinear combination of polynomials which represent the total cornealwavefront aberrations. According to one important aspect of the presentinvention, characterization of corneas is conducted on a selectedpopulation with the purpose of expressing an average of cornealwavefront aberrations and designing a lens from such averagedaberrations. Average corneal wavefront aberration terms of thepopulation can then be calculated, for example as an average linearcombination of polynomials and used in the lens design method. Thisaspect includes selecting different relevant populations, for example inage groups, to generate suitable average corneal surfaces.Advantageously, lenses can thereby be provided which are adapted to anaverage cornea of a population relevant for an individual elected toundergo cataract surgery or refractive correction surgery includingimplantation of an IOL or corneal inlays. The patient will therebyobtain a lens that gives the eye substantially less aberrations whencompared to a conventional spherical lens.

Preferably, the mentioned corneal measurements also include themeasurement of the corneal refractive power. The power of the cornea andthe axial eye length are typically considered for the selection of thelens power in the inventive design method.

Also preferably, the wavefront aberrations herein are expressed as alinear combination of polynomials and the optical system comprising thecorneal model and modeled intraocular lens provides for a wavefronthaving obtained a substantial reduction in aberrations, as expressed byone or more such polynomial terms. In the art of optics, several typesof polynomials are available to skilled persons for describingaberrations. Suitably, the polynomials are Seidel or Zernikepolynomials. According to the present invention Zernike polynomialspreferably are employed.

The technique of employing Zernike terms to describe wavefrontaberrations originating from optical surfaces deviating from beingperfectly spherical is a state of the art technique and can be employedfor example with a Hartnann-Shack sensor as outlined in J. Opt. Soc.Am., 1994, Vol. 11(7), pp. 1949-57. It is also well established amongoptical practitioners that the different Zernike terms signify differentaberration phenomena including defocus, astigmatism, coma and sphericalaberration up to higher aberrations. In an embodiment of the presentmethod, the corneal surface measurement results in that a cornealsurface is expressed as a linear combination of the first 15 Zernikepolynomials. By means of a raytracing method, the Zernike descriptioncan be transformed to a resulting wavefront (as described in Equation(1)), wherein Z_(i) is the i-th Zernike term and a_(i) is the weightingcoefficient for this term. Zernike polynomials are a set of completeorthogonal polynomials defined on a unit circle. Below, Table 1 showsthe first 15 Zernike terms and the aberrations each term signifies.$\begin{matrix}{{z( {\rho,\theta} )} = {\sum\limits_{i = 1}^{15}{a_{i}Z_{i}}}} & (1)\end{matrix}$

In equation (1), ρ and θ represent the normalized radius and the azimuthangle, respectively. TABLE 1 i Z_(i) (ρ,θ) 1 1 Piston 2 2ρcosθ Tilt x 32ρsinθ Tilt y 4 $\sqrt{3}( {{2\rho^{2}} - 1} )$ Defocus 5$\sqrt{6}( {\rho^{2}\quad\sin\quad 2\theta} )$ Astigmatism1^(st) order (45°) 6$\sqrt{6}( {\rho^{2}\quad\cos\quad 2\theta} )$ Astigmatism1^(st) order (0°) 7$\sqrt{8}( {{3\rho^{3}} - {2\rho}} )\quad\sin\quad\theta$Coma y 8 $\sqrt{8}( {{3\rho^{3}} - {2\rho}} )\cos\quad\theta$Coma x 9 $\sqrt{8}( {\rho^{3}\quad\sin\quad 3\theta} )$Trifoil 30° 10 $\sqrt{8}( {\rho^{3}\quad\cos\quad 3\theta} )$Trifoil 0° 11 $\sqrt{5}( {{6\rho^{4}} - {6\rho^{2}} + 1} )$Spherical aberration 12$\sqrt{10}( {{4\rho^{4}} - {3\rho^{2}}} )\quad\cos\quad 2\quad\theta$Astigmatism 2^(nd) order (0°) 13$\sqrt{10}( {{4\rho^{4}} - {3\rho^{2}}} )\quad\sin\quad 2\quad\theta$Astigmatism 2^(nd) order (45°) 14$\sqrt{10}( {\rho^{4}\quad\cos\quad 4\theta} )$ Tetrafoil 0°15 $\sqrt{10}( {\rho^{4}\quad\sin\quad 4\theta} )$ Tetrafoil22.5°

Conventional optical correction with intraocular lenses will only complywith the fourth term of an optical system comprising the eye with animplanted lens. Glasses, contact lenses and some special intra ocularlenses provided with correction for astigmatism can further comply withterms five and six and substantially reducing Zernike polynomialsreferring to astigmatism.

The inventive method further includes to calculate the wavefrontaberrations resulting from an optical system comprising said modeledintraocular lens and cornea and expressing it in a linear combination ofpolynomials and to determine if the intraocular lens has providedsufficient reduction in wavefront aberrations. If the reduction inwavefront aberrations is found to be insufficient, the lens will bere-modeled until one or several of the polynomial terms are sufficientlyreduced. Remodeling the lens means that at least one lens designparameter is changed. These include the anterior surface shape andcentral radius, the posterior surface shape and central radius, thethickness of the lens and its refractive index. Typically, suchremodeling includes changing the shape of a lens surface so it deviatesfrom being a spherical. There are several tools available in lens designthat are useful to employ with the design method, such as OSLO version 5see Program Reference, Chapter 4, Sinclair Optics 1996. The format ofthe Zernike polynomials associated with this application are listed inTable 1.

According to a preferred aspect of the first embodiment, the inventivemethod comprises expressing at least one corneal surface as a linearcombination of Zernike polynomials and thereby determining the resultingcorneal wavefront Zernike coefficients, i.e. the coefficient of each ofthe individual Zernike polynomials that is selected for consideration.The lens is then modeled so that an optical system comprising of saidmodel lens and cornea provides a wavefront having a sufficient reductionof selected Zermike coefficients. The method can optionally be refinedwith the further steps of calculating the Zernike coefficients of theZernike polynomials representing a wavefront resulting from an opticalsystem comprising the modeled intraocular lens and cornea anddetermining if the lens has provided a sufficient reduction of thewavefront Zernike coefficients of the optical system of cornea and lens;and optionally re-modeling said lens until a sufficient reduction insaid coefficients is obtained. Preferably, in this aspect the methodconsiders Zernike polynomials up to the 4th order and aims tosufficiently reduce Zernike coefficients referring to sphericalaberration and/or astigmatism terms. It is particularly preferable tosufficiently reduce the 11th Zernike coefficient of a wavefront frontfrom an optical system comprising cornea and said modeled intraocularlens, so as to obtain an eye sufficiently free from sphericalaberration. Alternatively, the design method can also include reducinghigher order aberrations and thereby aiming to reduce Zernikecoefficients of higher order aberration terms than the 4^(th) order.

When designing lenses based on corneal characteristics from a selectedpopulation, preferably the corneal surfaces of each individual areexpressed in Zernike polynomials describing the surface topography andtherefrom the Zernike coefficients of the wavefront aberration aredetermined. From these results average Zernike wavefront aberrationcoefficients are calculated and employed in the design method, aiming ata sufficient reduction of selected such coefficients. In an alternativemethod according to the invention, average values of the Zernikepolynomials describing the surface topography are instead calculated andemployed in the design method. It is to be understood that the resultinglenses arriving from a design method based on average values from alarge population have the purpose of substantially improving visualquality for all users. A lens having a total elimination of a wavefrontaberration term based on an average value may consequently be lessdesirable and leave certain individuals with an inferior vision thanwith a conventional lens. For this reason, it can be suitable to reducethe selected Zernike coefficients only to certain degree of the averagevalue.

According to another approach of the inventive design method, cornealcharacteristics of a selected population and the resulting linearcombination of polynomials, e.g. Zernike polynomials, expressing eachindividual corneal aberration can be compared in terms of coefficientvalues. From this result, a suitable value of the coefficients isselected and employed in the inventive design method for a suitablelens. In a selected population having aberrations of the same sign sucha coefficient value can typically be the lowest value within theselected population and the lens designed from this value would therebyprovide improved visual quality for all individuals in the groupcompared to a conventional lens.One embodiment of the method comprisesselecting a representative group of patients and collecting cornealtopographic data for each subject in the group. The method comprisesfurther transferring said data to terms representing the corneal surfaceshape of each subject for a preset aperture size representing the pupildiameter. Thereafter a mean value of at least one corneal surface shapeterm of said group is calculated, so as to obtain at least one meancorneal surface shape term. Alternatively or complementary a mean valueof at least one to the cornea corresponding corneal wavefront aberrationterm can be calculated. The corneal wavefront aberration terms areobtained by transforming corresponding corneal surface shape terms usinga raytrace procedure. From said at least one mean corneal surface shapeterm or from said at least one mean corneal wavefront aberration term anophthalmic lens capable of reducing said at least one mean wavefrontaberration term of the optical system comprising cornea and lens isdesigned.

In one preferred embodiment of the invention the method furthercomprises designing an average corneal model for the group of peoplefrom the calculated at least one mean corneal surface shape term or fromthe at least one mean corneal wavefront aberration term. It alsocomprises checking that the designed ophthalmic lens compensatescorrectly for the at least one mean aberration term. This is done bymeasuring these specific aberration terms of a wavefront having traveledthrough the model average cornea and the lens. The lens is redesigned ifsaid at least one aberration term has not been sufficiently reduced inthe measured wavefront.

Preferably one or more surface descriptive (asphericity describing)constants are calculated for the lens to be designed from the meancorneal surface shape term or from the mean corneal wavefront aberrationterms for a predetermined radius. The spherical radius is determined bythe refractive power of the lens.

The corneal surfaces are preferably characterized as mathematical modelsand the resulting aberrations of the corneal surfaces are calculated byemploying the mathematical models and raytracing techniques. Anexpression of the corneal wavefront aberrations is thereby obtained,i.e. the wavefront aberrations of a wavefront having passed such acorneal surface. Dependent on the selected mathematical model differentroutes to calculate the corneal wavefront aberrations can be taken.Preferably, the corneal surfaces are characterized as mathematicalmodels in terms of a conoid of rotation or in terms of polynomials or acombination thereof. More preferably, the corneal surfaces arecharacterized in terms of linear combinations of polynomials.

In one embodiment of the invention, the at least one nonspheric surfaceof the lens is designed such that the lens, in the context of the eye,provides to a passing wavefront at s least one wavefront aberration termhaving substantially the same value but with opposite sign to a meanvalue of the same aberration term obtained from corneal measurements ofa selected group of people, to which said patient is categorized. Herebya wavefront arriving from the cornea of the patient's eye obtains areduction in said at least one aberration term provided by the corneaafter passing said lens. The used expression in the context of the eye'can mean both in the real eye and in a model of an eye. In a specificembodiment of the invention, the wavefront obtains reduced aberrationterms expressed in rotationally symmetric Zernike terms up to the fourthorder. For this purpose, the surface of the ophthalmic lens is designedto reduce a positive spherical aberration term of a passing wavefrontThe consequence of this is that if the cornea is a perfect lens and thusnot will give rise to any wavefront aberration terms the ophthalmic lenswill provide the optical system comprising the cornea and the ophthalmiclens with a negative wavefront spherical aberration term. In this textpositive spherical aberration is defined such that a spherical surfacewith positive power produces positive spherical aberration. Preferablythe lens is adapted to compensate for spherical aberration and morepreferably it is adapted to compensate for at least one term of aZernike polynomial representing the aberration of a wavefront,preferably at least the 11^(th) Zernike term, see Table 1.

The selected groups of people could for example be a group of peoplebelonging to a specific age interval, a group of people who will undergoa cataract surgical operation or a group of people who have undergonecorneal surgery including but not limited to LASIK (laser in situkeratomileusis), RK (radial keratotomy) or PRK (photorefractivekeratotomy). The group could also be a group of people who have aspecific ocular disease or people who have a specific ocular opticaldefect.

The lens is also suitably provided with an optical power. This is doneaccording to conventional methods for the specific need of opticalcorrection of the eye. Preferably the refractive power of the lens isless than or equal to 30 diopters. An optical system considered whenmodeling the lens to compensate for aberrations typically includes theaverage cornea and said lens, but in the specific case it can alsoinclude other optical elements including the lenses of spectacles, or anartificial correction lens, such as a contact lens, a corneal inlay oran implantable correction lens depending on the individual situation.

In an especially preferred embodiment the ophthalmic lens is designedfor people who will undergo a cataract surgery. In this case it is hasbeen shown that the average cornea from such a population is representedby a prolate surface following the formula:$z = {\frac{( {1/R} )r^{2}}{1 + \sqrt{1 - {( \frac{1}{R} )^{2}( {{cc} + 1} )r^{2}}}} + {adr}^{4} + {aer}^{6}}$wherein,

-   (i) the conical constant cc has a value ranging between −1 and 0-   (ii) R is the central lens radius and-   (iii) ad and ae are aspheric polynomial coefficients additional to    the conical constant.

In these studies the conic constant of the prolate surface rangesbetween about −0.05 for an aperture size (pupillary diameter) of 4 mm toabout −0.18 for an aperture size of 7 mm. Accordingly an ophthalmic lenssuitable to improve visual quality by reducing at least sphericalaberration for a cataract patient based on an average corneal value willhave a prolate surface following the formula above. Since corneagenerally produces a positive spherical aberration to a wavefront in theeye, an ophthalmic lens for implantation into the eye will have negativespherical aberration terms while following the mentioned prolate curve.As will discussed in more detail in the exemplifying part of thespecification, it has been found that an intraocular lens that cancorrect for 100% of a mean spherical aberration has a conical constant(cc) with a value of less than 0 (representing a modified conoidsurface), with an exact value dependent on the design pupillary diameterand the selected refractive power. For example, a 6 mm diameter aperturewill provide a 22 diopter lens with conical constant value of about−1.03. In this embodiment, the ophthalmic lens is designed to balancethe spherical aberration of a cornea that has a Zernike polynomialcoefficient representing spherical aberration of the wavefrontaberration with a value in the interval from 0.000156 mm to 0.001948 mmfor a 3 mm aperture radius, 0.000036 mm to 0.000448 mm for a 2 mmaperture radius, 0.0001039 mm to 0.0009359 mm for a 2.5 mm apertureradius and 0.000194 mm to 0.00365 mm for a 3.5 mm aperture radius usingpolynomials expressed in OSLO format. These values were calculated for amodel cornea having a single surface with a refractive index of thecornea of 1.3375. It is possible to use optically equivalent modelformats of the cornea without departing from the scope of the invention.For example multiple surface corneas or corneas with differentrefractive indices could be used. The lower values in the intervals arehere equal to the measured average value for that specific apertureradius minus one standard deviation. The higher values are equal to themeasured average value for each specific aperture radius plus threestandard deviations. The used average values and standard deviations areshown in tables 8,9,10 and 11. The reason for selecting only minus oneSD (=Standard Deviation) while selecting plus three SD is that in thisembodiment it is convenient to only compensate for positive cornealspherical aberration and more than minus one SD added to the averagevalue would give a negative corneal spherical aberration.

According to one embodiment of the invention the method furthercomprises the steps of measuring the at least one wavefront aberrationterm of one specific patient's cornea and determining if the selectedgroup corresponding to this patient is representative for this specificpatient. If this is the case the selected lens is implanted and if thisis not the case a lens from another group is implanted or an individuallens for this patient is designed using this patients cornealdescription as a design cornea. These method steps are preferred sincethen patients with extreme aberration values of their cornea can begiven special treatments.

According to another embodiment, the present invention is directed tothe selection of an intraocular lens of refractive power, suitable forthe desired optical correction that the patient needs, from a pluralityof lenses having the same power but different aberrations. The selectionmethod is similarly conducted to what has been described with the designmethod and involves the characterizing of at least one corneal surfacewith a mathematical model by means of which the aberrations of thecorneal surface is calculated. The optical system of the selected lensand the corneal model is then evaluated so as to consider if sufficientreduction in aberrations is accomplished by calculating the aberrationsof a wavefront arriving from such a system. If an insufficientcorrection is found a new lens is selected, having the same power, butdifferent aberrations. The mathematical models employed herein aresimilar to those described above and the same characterization methodsof the corneal surfaces can be employed.

Preferably, the aberrations determined in the selection are expressed aslinear combinations of Zernike polynomials and the Zernike coefficientsof the resulting optical system comprising the model cornea and theselected lens are calculated. From the coefficient values of the system,it can be determined if the intraocular lens has sufficiently balancedthe corneal aberration terms, as described by the Zernike coefficientsof the optical system. If no sufficient reduction of the desiredindividual coefficients are found these steps can be iterativelyrepeated by selecting a new lens of the same power but with differentaberrations, until a lens capable of sufficiently reducing theaberrations of the optical system is found. Preferably at least 15Zernike polynomials up to the 4^(th) order are determnined. If it isregarded as sufficient to correct for spherical aberration, only thespherical aberration terms of the Zernike polynomials for the opticalsystem of cornea and intraocular lens are corrected. It is to beunderstood that the intraocular lens shall be selected so a selection ofthese terms become sufficiently small for the optical system comprisinglens and cornea. In accordance with the present invention, the 11^(th)Zernike coefficient, a₁₁, can be substantially eliminated or broughtsufficiently close to zero. This is a prerequisite to obtain anintraocular lens that sufficiently reduces the spherical aberration ofthe eye. The inventive method can be employed to correct for other typesof aberrations than spherical aberration by considering other Zernikecoefficients in an identical manner, for example those signifyingastigmatism, coma and higher order aberrations. Also higher orderaberrations can be corrected dependent on the number of Zernikepolynomials elected to be a part of the modeling, in which case a lenscan be selected capable of correcting for higher order aberrations thanthe 4^(th) order.

According to one important aspect, the selection method involvesselecting lenses from a kit of lenses having lenses with a range ofpower and a plurality of lenses within each power having differentaberrations. In one example the lenses within each power have anteriorsurfaces with different aspherical components. If a first lens does notexhibit sufficient reduction in aberration, as expressed in suitableZernike coefficients, then a new lens of the same power, but with adifferent surface (aspheric component) is selected. The selection methodcan if necessary be iteratively repeated until the best lens is found orthe studied aberration terms are reduced below a significant borderlinevalue. In practice, the Zernike terms obtained from the cornealexamination will be directly obtained by the ophthalmic surgeon and bymeans of an algorithm they will be compared to known Zernike terms ofthe lenses in the kit. From this comparison the most suitable lens inthe kit can be found and implanted. Alternatively, the method can beconducted before cataract surgery and data from the corneal estimationis sent to a lens manufacturer for production of an individuallytailored lens.

The present invention further pertains to an intraocular lens having atleast one nonspherical surface capable of transferring a wavefronthaving passed through the cornea of the eye into a substantiallyspherical wavefront with its center at the retina of the eye.Preferably, the wavefront is substantially spherical with respect toaberration terms expressed in rotationally symmetric Zernike terms up tothe fourth order.

In accordance with an especially preferred embodiment, the inventionrelates to an intraocular lens, which has at least one surface, whenexpressed as a linear combination of Zernike polynomial terms using thenormalized format, that has a negative 11^(th) term of the fourth orderwith a Zernike coefficient a₁₁ that that can balance a positive suchterm of the cornea to obtain sufficient reduction of the sphericalaberration of the eye after implantation. In one aspect of thisembodiment, the Zernike coefficient a₁₁ of the lens is determined so asto compensate for an average value resulting from a sufficient number ofestimations of the Zernike coefficient a₁₁ in several corneas. Inanother aspect, the Zernike coefficient a₁₁ is determined to compensatefor the individual corneal coefficient of one patient. The lens canaccordingly be tailored for an individual with high precision.

The invention further relates to another method of providing a patientwith an intraocular lens, which at least partly compensates for theaberrations of the eye. This method comprises removing the natural lensfrom the eye. Surgically removing the impaired lens can be performed byusing a conventional phacoemulsification method, The method furthercomprises measuring the aberrations of the aphakic eye, not comprising alens, by using a wavefront sensor. Suitable methods for wavefrontmeasurements are found in J.Opt.Soc.Am., 1994, Vol. 11(7), pp. 1949-57by Liang et, al. Furthermore, the method comprises selecting from a kitof lenses a lens that at least partly compensates for the measuredaberrations and implanting said lens into the eye. The kit of lensescomprises lenses of different power and different aberrations andfinding the most suitable lens can be performed in a manner as earlierdiscussed. Alternatively, an individually designed lens for the patientcan be designed based on the wavefront analysis of the aphakic eye forsubsequent implantation. This method is advantageous, since notopographical measurements of the cornea are and the whole cornea,including the front and back surfaces, is automatically considered.

The lenses according to the present invention can be manufactured withconventional methods. In one embodiment they are made from soft,resilient material, such as silicones or hydrogels. Examples of suchmaterials suitable for foldable is intraocular lenses are found in U.S.Pat. No. 5,444,106 or in U.S. Pat. No. 5,236,970. Manufacturing ofnonspherical silicone lenses or other foldable lenses can be performedaccording to U.S. Pat. No. 6,007,747. Alternatively, the lensesaccording to the present invention can be made of a more rigid material,such as poly(methyl)methacrylate. The skilled person can readilyidentify alternative materials and manufacturing methods, which will besuitable to employ to produce the inventive aberration reducing lenses.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a comparison of the a₁₁ (“Z11”) Zernike coefficient valuesfor 10 subjects if implanted with CeeOn® 911 lenses and the inventiveaveraged (“Z11”) lens.

FIG. 2 shows modeled visual acuities of the test subjects with CeeOn®911 lenses and the inventive averaged (“Z11”) lenses.

FIG. 3 and FIG. 4 show modulation transfer function comparisons betweenCeeOn® 911 lenses and the inventive averaged (“Z11”) lenses

FIG. 5 shows visual acuity plotted as a function of the astigmatism ofthe lenses according to the model lenses according to the invention.

FIG. 6 shows the best corrected visual acuity with the inventive lenses.

FIG. 7 and 8 show modulation transfer functions of an individual with anindividually designed lens.

FIG. 9 shows the best corrected visual acuity with individually designedlenses according to the invention.

FIG. 10 shows the age distribution of 71 patients used in a studydescribed below in the example part.

FIG. 11 shows a height map given by an Orbscan® true height data file.

FIG. 12 shows average corneal wavefront aberration coefficients.

FIG. 13 shows a scatter plot of the spherical aberration of 71 subjectsfor a 6 mm diameter aperture.

FIG. 14 shows a scatter plot of the spherical aberration of 71 subjectsfor a 4 mm diameter aperture.

FIG. 15 shows a scatter plot of the spherical aberration of 71 subjectsfor a 5 mm diameter aperture.

FIG. 16 shows a scatter plot of the spherical aberration of 71 subjectsfor a 7 mm diameter aperture.

EXAMPLE 1

A sample set of 10 corneal surfaces from individuals were describedusing Zernike polynomials. The sag data of the corneas was determinedusing the real height data measured with a Humphrey Atlas cornealtopographer. The corneal topographer measures the height (z_(i)) at adiscrete number of points. The corneal surface can then be expressed asa linear combination of the first 15 Zernike polynomials (as describedin Equation 1, above), where Z_(i) is the ith Zernike polynomial and asis the weighting coefficient for this polynomial. The Zernikepolynomials are a set of complete orthogonal polynomials defined on aunit circle. These polynomials as listed in Table 1 above and theweighting coefficients (a_(i)) are calculated from the height data usinga Grahm-Schmidt orthogonalization procedure. The Zernike coefficients(a_(i)) for the 10 sample corneas are listed in Table 2 in mm. TABLE 2The Zernike coefficients for the 10 individual corneal surfaces in mm.ACH ASA CGR CNR FCA FCM FCZ FGP JAE JBH a1 −7.713337 −6.698643 −7.222353−7.169027 −7.001356 −7.322624 −7.03713 −7.84427 −7.582005 −6.890056 a20.000271 −0.000985 0.000386 −0.000519 0.000426 −0.000094 −0.000236−0.00056 −0.000344 −0.000155 a3 0.000478 −0.000002 −0.000847 0.000996−0.000393 0.000045 0.000454 0.000347 0.000246 −0.000558 a4 0.0733090.083878 0.077961 0.078146 0.080111 0.077789 0.079987 0.072595 0.0758030.081415 a5 −0.000316 −0.000753 0.000119 0.000347 −0.001197 0.00022−0.000071 0.000686 −0.000388 −0.000269 a6 0.001661 0.000411 −0.000148−0.000386 0.000314 0.000669 0.00079 −0.00048 0.001688 0.001492 a70.000193 0.00006 −0.000295 0.000324 −0.000161 −0.000058 0.000148 0.000140.000104 −0.000227 a8 0.000098 −0.000437 0.000146 −0.00018 0.0001470.000039 −0.000076 −0.00025 −0.000173 −0.000116 a9 −0.000091 −0.000168−0.000107 0.000047 −0.000181 −0.000154 −0.000043 0.000092 −0.000023−0.000109 a10 −0.000055 0.000139 −0.000132 −0.000149 0.000234 −0.0002280.000244 −8.2E−05 −0.000004 0.000065 a11 0.000277 0.000394 0.0002030.000305 0.000285 0.000315 0.000213 0.000308 0.000309 0.0004 a12−0.000019 −0.000105 0.000025 0.00007 −0.000058 −0.000033 0.00009  −2E−06 −0.000115 −0.00011 a13 0.000048 0.000032 0.000085 0.0000170.000039 0.000059 0.000022 0.000101 −0.000042 −0.000052 a14 −0.0000670.000041 −0.000081 −0.000049 0.000118 −0.000108 0.000127 −1.9E−05−0.000068 0.00001 a15 −0.000048 −0.000075 −0.000073 −0.000019 −0.000036−0.000119 −0.000021 0.000022 −0.000013 −0.000048

These wavefront aberration coefficients can be calculated using opticaldesign software such as OSLO (Sinclair Optics). Table 3 shows theresults of calculating the wavefront aberration for subject FCM. (N.B.The normalization factor for the polynomials used in OSLO is differentfrom those shown in Table 3. This difference has been incorporated intothe coefficient values.) TABLE 3 The corneal aberration coefficients inmm calculated for subject FCM using OSLO (N.B. OSLO numbering order)Aberration Coefficients for FCM (OSLO) A0 −0.000123 A1 4.5960e−07 A22.0869e−07 A3 −5.355e−06 A4  0.000551 A5  0.000182 A6 3.7296e−05 A7−5.5286e−05  A8  0.000116 A9 −0.000217 A10 −0.000147 A11 −3.8151e−05 A12 6.1808e−05 A13 −3.3056e−07  A14  4.888e−07 A15 −1.8642e−06  A16−0.000115 A17 −0.000127

EXAMPLE 2

An averaged design embodiment of the inventive lenses has beencalculated using the average “old” cornea information provided by PabloAnal, Murcia, Spain. This data was taken from a population sample of 16old corneas in which all of the subjects had a visual acuity of 20/30 orbetter. The corneal surfaces were described using Zernike polynomialsfor an aperture of 2.0 mm radius (r₀). The polynomial coefficients werethen used to determine the radius and asphericity values using Equations2 and 3. $\begin{matrix}{R = \frac{r_{0}^{2}}{2( {{2\sqrt{3}a_{4}} - {6\sqrt{5}a_{11}}} )}} & (2) \\{K^{2} = {\frac{8R^{3}}{r_{0}^{4}}6\sqrt{5}a_{11}}} & (3)\end{matrix}$

Note that the asphericity constant, K, describes the surface's variationfrom a sphere (K²=1−e²). (i.e. For a sphere K=1 and for a parabola K=0).(cc K²−1, wherein cc is the conical constant)

Because the cornea surface has only been described for a centraldiameter of 4 mm, the calculated R and K are also only accurate over thecentral 4 mm. A pupil size of 4.0 mm is therefore selected for designpurposes. This pupil size is reasonable for intraocular lens designpurposes.

A 22D CeeOn® 911 lens from Pharmacia Corp was chosen as a starting pointfor the averaged lens design. For the purpose of comparison, theaveraged lenses were also designed to be 22D. (Note that other dioptreswould give similar simulation results, provided that the sphericalsurfaces of the lenses is the same.) The surface information for thestarting point eye model is summarized in Table 4. In the conical andaspheerical data demonstrated in Table 4, the average conic constant CCis determined for the 10 individual corneas of Example 1. TABLE 4Surface data for the starting point of the averaged (“Z11”) designRadius Thickness Aperture Conic Refractive Surface # (mm) (mm) Radius(mm) Constant Index Object — ∞ 2.272611 1.0 1 7.573 3.6 2.272611−0.0784* 1.3375 (cornea) 2 (pupil) — — 2.0 — 1.3375 3 — 0.9 2.0 — 1.33754 (lens 11.043 1.14 3.0 — 1.4577 1) 5 (lens −11.043 17.2097 3.0 — 1.3362)*This conic constant for the “average” cornea is taken from thepublished works of Guirao and Artal

The wavefront aberration coefficients in mm for the average cornea areshown in column 1 of Table 5, while the coefficients in mm of thecombination of the average cornea and the 911 lens are shown in column 2of Table 5. Note that the Z11 coefficient (a11) of the average oldcornea alone is 0.000220 mm, while the Z11 of this eye implanted with a911 would be 0.000345 mm. TABLE 5 Zernike coefficients in mm of theaverage cornea and the starting point for design (Average cornea + 911)Average Cornea Average Cornea + 911 a1 0.000432 0.000670 a2 0.0 0.0 a30.0 0.0 a4 0.000650 0.00101 a5 0.0 0.0 a6 0.0 0.0 a7 0.0 0.0 a8 0.0 0.0a9 0.0 0.0 a10 0.0 0.0 a11 0.000220 0.000345 a12 0.0 0.0 a13 0.0 0.0 a140.0 0.0 a15 0.0 0.0

The averaged lens was optimized to minimize spherical aberration, whilemaintaining a 22D focal power. The lens material remained the same as inthe 22D 911 lens (HRI silicone, the refractive index of which is 1.45in77 at 37° C. The resulting design for an equiconvex lens is Theaveraged lens was optimized to minimize spherical aberration, whilemaintaining a 22D focal power. The lens material remained the same as inthe 22D 911 lens (HRI silicone, the refractive The resulting design foran equiconvex lens is provided in Table 6. The total-eye Z11 coefficientof the average cornea combined with this lens is −2.42×10⁻⁷ mm(versus0.000345 mm for the cornea plus 911 lens). TABLE 6 Surface data for thestarting point of the averaged lens design 4^(th) Order 6^(th) OrderRadius Thickness Aperture Conic Aspheric Aspheric Refractive Surface #(mm) (mm) Radius (mm) Constant Constant Constant Index Object — ∞2.272611 1.0 1 (cornea) 7.573 3.6 2.272611 −0.0784 1.3375 2 (pupil) — —2.0 — 1.3375 3 — 0.9 2.0 — 1.3375 4 (lens 1) 10.0 1.02 3.0 −2.809−0.000762 −1.805e−05 1.4577 5 (lens 2) −12.0 17.2097 3.0 — 1.336

The corneas of the 10 test subjects were combined in an optical systemwith both the 911 and the averaged lenses. The resulting total-eye Z11coefficients are shown in FIG. 1. As demonstrated, in FIG. 1, in eachcase, the absolute value of the Z11 coefficient was less when the Z11lens was implanted. Because subjects CGR and FCZ have relatively lowlevels of corneal spherical aberration to begin with, the total-eyespherical aberration is overcorrected in these two cases. As a result,the sign of the total spherical aberration is noticeably reversed inthese two cases, and the amount of spherical aberration is stillsignificant. In every other case, the spherical aberration of the totaleye would be essentially 0 after the implantation of a Z11 lens. Thevisual acuity of each of the 10 test subjects were calculated accordingto standard methods described in “Visual acuity modeling using opticalraytracing of schematic eyes”, Greivenkamp et al., American journal ofophthalmology, 120(2), 227-240, (1995), for the implantation of both a22D 911 lens and a 22D averaged “Z11” lens. The square wave responseswere calculated using OSLO™ and a software module was written in Matlab™to calculate the visual acuity following the above method. The resultingvisual acuities are shown in FIG. 2. Out of the 10 cases investigatedand shown in FIG. 2, eight subjects had better vision when implantedwith the averaged lens according to the present invention. In the caseswhere the visual acuity decreased their Snellen distance increased byless than 1 ft which would not show up in visual acuity testing.

To be able to assess the optical quality difference between a CeeOn®911A and averaged lenses according to the present invention, a physicalmodel of the average cornea was designed and manufactured. It is aconvex-plano lens of PMMA with an aspheric front surface having a valueof 0.000218 for Zernike coefficient a11. This value is almost equal tothe value of the calculated average corneas 0.000220. With the PMMAmodel cornea MTF measurements were performed on an optical bench in amodel eye with the “averaged” Z11 lenses and CeeOn® 911A lenses.Modulation Transfer Function (MTF) measurements are a widely acceptedmethod of quantifying image quality. Through focus MTF measurements at50 c/mm and a frequency MTF curves focussed at 50 c/mm, in both caseswith a 3 mm pupil are shown in the FIG. 3 and FIG. 4, respectively forlenses with an optical power of 20 D). The width of the through focusMTF at 0.2 MTF units is a measure for the depth of focus and is equalfor both lenses. The MTF curve focussed at 50 c/mm for “averaged” Z11lenses is almost diffraction limited and is better than that for CeeOn911A lenses.

The astigmatism of the cornea and the defocus of the system can becorrected by adjusting the Zernike coefficients of the cornea model andthe focal position of the system. When this is done and the procedurefor calculating visual acuity is repeated the results in FIG. 6 areobtained, They represent a modeled best corrected visual acuity We nowsee that, in all cases, after correction for astigmatism and defocus (asin reality would be done with spectacles) the inventive averaged lensproduces a higher best corrected visual acuity than the 911 lens of thesame dioptre.

EXAMPLE 3

Individually Designed Lenses:

As a potential further improvement upon the averaged lens (“Z11lenses”), an individualized lens (“I11 lenses”) was designed for each offour subject corneas employing the same design principles asdemonstrated in Example 2. The individual lenses were designed such thatthe Z11 of the lens balances the Z11 of the individual cornea. Thetotal-eye Z11 coefficients for the I11 lenses are shown in Table 7,together TABLE 7 The Z11 coefficients in mm of the model eyes with the911, Z11 and I11 lenses Subject 911 averaged individual CGR 0.000107−0.000101 −0.000004 FCZ 0.000105 −0.000100 −0.000005 JAE 0.000195−0.000016 −0.000012 JBH 0.000238 0.000037 −0.000019with the corresponding coefficients for the 911 and the averaged lenses.Furthermore, for each of the 911, Z11 (averaged), and I11 (individual)lenses, the MTF curve at best focussed at 50 c/mm and the through focusMTF at 50 c/mm for subject JAE are plotted below in FIG. 7 and 8. FromFIG. 7 and 8, it is seen that the MTF at 50 c/mm of eyes implanted withthe Z11 and I11 lenses is higher than the MTF of the same eyes implantedwith 911 lenses. It can also be seen that the through focus MTF of allof the lenses is satisfactory. The Z11 has as much depth of focus as the911. However, it is also interesting to note that the I11 does notprovide a significant improvement in either MTF or through focus MTF,relative to the Z11 lens.

The visual acuities of the subjects with individualized lenses have alsobeen calculated. FIG. 9 compares these acuities with the visual acuitycalculated for the 911 and Z11 lenses.

From FIG. 9, we see that for all 4 subjects, visual acuity is better forboth the Z11 and I11 lenses than it is for the 911 lens. We also seethat the results with the Z11 and I11 lenses do not differsignificantly—the average cornea is relatively accurate for each of the4 test subjects.

EXAMPLE 4

The design of an ophthalmic lens, which is adapted to reduce thespherical aberration of an average cornea obtained from a group ofpeople will be described in detail here below. The lens will be calledthe Z11 lens because it compensates for the normalized 11^(th) Zerniketerm describing spherical aberration of the corneas. It was decided touse a population of potential recipients of the Z11lens, namely cataractpatients.

Description of the Population:

The population included 71 cataract patients from St. Erik's eyehospital in Stockholm, Sweden. These patients were of ages ranging from35 to 94 years (as of Apr. 12, 2000). The average age of our populationwas 73.67 years. A histogram of the age of the population is shown inFIG. 10.

The corneas of the 71 subjects were measured using an Orbscan® (Orbtek,Salt Lake City) device. Orbscan® is a scanning slit-based, corneal andanterior segment topographer that measures both surfaces of the cornea,as well as the anterior lens surface and the iris. Each surface can bedisplayed as maps of elevation, inclination, curvature, and power.

Fitting Algorithm:

The corneal elevation height data (the Cartesian locations of points onthe surface of the cornea) for the anterior surface was obtained usingthe Orbscan®, and used as raw data for the determination of the opticalproperties of the cornea. The height data from an example Orbscan® fileis represented in FIG. 11.

The Cartesian co-ordinates representing the elevation height data aretransformed to polar co-ordinates (x,y,z→r,θ,z). In order to describethe surface, this data is then fit to a series of polynomials asdescribed in Equation 1b. The coefficients (a′s), or weighting factors,for each polynomial are determined by the fitting procedure resulting ina complete description of the surface. The polynomials (Z_(i)) used arethe normalized Zernike polynomials. $\begin{matrix}{{z( {\rho,\theta} )} = {\sum\limits_{i = 1}^{L}{a_{i}Z_{i}}}} & ( {1b} )\end{matrix}$

These polynomials are special because they are orthonormal over acontinuous unit circle. They are commonly used to describe wavefrontaberrations in the field of optics. Corneal topographers measure theelevation heights at a discrete number of points. The Zernikepolynomials are not orthogonal over a discrete set of points. However,applying an orthogonalization procedure, termed Gram-Schmidtorthogonalization, to the height data, allows the data to be fit interms of Zernike polynomials maintaining the advantages of an orthogonalfit. Sixty-six coefficients (a′s) were used to fit the height dataprovided by the Orbscan® software. A Matlab™ algorithm was used in thefitting procedure. The radius and asphericity value can be approximatedfrom the Zernike coefficients (Equations 2b and 3b) and the conicconstant of the surface is simply K²−1 (from this we know that for asphere K²=1). The fitting procedure is well described in a number ofreferences. Four different articles are refereed to here: “Wavefrontfitting with discrete orthogonal polynomials in a unit radius circle”,Daniel Malacara, Optical Engineering, June 1990, Vol. 29 No. 6“Representation of videokeratoscopic height data with Zernikepolynomials”, J. Schwiegerling, J. Greivenkamp and J. Miller, JOSA A,October 1995, Vol. 12 No. 10, “Wavefront interpretation with Zernikepolynomials” J. W. Wang and D. E. Silva, Applied Optics, May 1980, Vol.19, No. 9 and “Corneal wave aberration from videokeratography: accuracyand limitations of the procedure”, Antonio Guirao and Pablo Artal, J OptSoc Am A Opt Image Sci Vis Jun 2000, Vol. 17(6):955-65. $\begin{matrix}{R = \frac{r_{pupil}^{2}}{2( {{2\sqrt{3}a_{4}} - {6\sqrt{5}a_{11}}} )}} & ( {2b} )\end{matrix}$ $\begin{matrix}{K_{sq} = {\frac{8R^{3}}{r_{0}^{4}}6\sqrt{5}a_{11}}} & ( {3b} )\end{matrix}$Calculation of Wavefront Aberration:

Knowing the shape of the anterior corneal surface (Zernike coefficientsdescribed above as a′s), it is possible to determine the wavefrontaberration contributed by this surface using a raytrace procedure. Thisis described in for example “Corneal wave aberration fromvideokeratography: accuracy and limitations of the procedure”, AntonioGuirao and Pablo Artal, J Opt Soc Am A Opt Image Sci Vis Jun 2000, Vol.17(6):955-65.

Results:

Average Corneal Spherical Aberration and Shape:

The 71 subjects were evaluated using the criteria described above for a6 mm aperture. The wavefront aberration of each subject was determinedafter fitting the surface elevation with Zernike polynomials. FIG. 12shows that average and standard deviation of each Zernike term(normalized format). The error bars represent ±1 standard deviation.There are three aberrations that are significantly different from zeroon average in our population. These are astigmatism (A5), coma (A9) andspherical aberration (A11). Spherical aberration is the onlyrotationally symmetric aberration, making it the only aberration thatcan be corrected with a rotationally symmetric IOL.

FIG. 13 shows a scatter plot of the value of the Zernike coefficient(OSLO format) representing spherical aberration for each of the 71subjects before cataract surgery. The solid line in the middlerepresents the average spherical aberration, while the dotted linesrepresent +1 and −1 standard deviation. Table 8 lists the average,standard deviation, maximum and minimum values for the radius, asphericconstant, spherical aberration and root mean square error. TABLE 8 theaverage, standard deviation, maximum and minimum values for the radius,aspheric constant, spherical aberration and root mean square error for a6 mm aperture. Average Standard Value Deviation Maximum Minimum R (mm)7.575 0.333 8.710 7.072 Ksq 0.927 0.407 2.563 0.0152 SA coefficient0.000604 0.000448 0.002003 −0.000616 OSLO format (in mm) RMSE 0.0000550.00000482 0.000069 0.000045

Tables 9,10 and 11 below show the corresponding results for aperturesizes of 4,5 and 7 mm respectively. FIG. 14,15 and 16 are thecorresponding scatter plots. TABLE 9 The average, standard deviation,maximum and minimum values for the radius, aspheric constant, sphericalaberration and root mean square error using an aperture diameter of 4mm. Average Value Standard Deviation Maximum Minimum R 7.56292 0.3205268.688542 7.067694 Ksq 0.988208 0.437429 2.33501 −0.051091 SA (A110.000139 0.000103 0.00041 −0.000141 in mm) RMSE 4.52E−05 4E−06 0.0000540.000036

TABLE 10 The average, standard deviation, maximum and minimum values forthe radius, aspheric constant, spherical aberration and root mean squareerror using an aperture diameter of 5 mm. Standard Average ValueDeviation Maximum Minimum R 7.55263 0.320447 8.714704 7.09099 Ksq0.945693 0.364066 2.045412 0.044609 SA 0.00031189 0.000208 0.000793−0.000276 (A11 in mm) RMSE 4.7E−05 4.02E−06 0.000057 0.000037

TABLE 11 The average, standard deviation, maximum and minimum values forthe radius, aspheric constant, spherical aberration and root mean squareerror using an aperture diameter of 7 mm. Standard Average ValueDeviation Maximum Minimum R 7.550226 0.336632 8.679712 7.040997 Ksq0.898344 0.416806 2.655164 −0.04731 SA 0.001058 0.000864 0.003847−0.001319 (A11 in mm) RMSE 7.58E−05 1.02E−05 0.000112 0.000057Design Cornea:

One model cornea was designed and each Z11 lens power was designed usingthis cornea. The cornea was designed so that it had a sphericalaberration that is the same as the average calculated for thepopulation. The design cornea radii and aspheric constants are listed inTable 12 for different aperture sizes. In every case, the radius ofcurvature was taken to be the average radius determined from the Zernikefit data. The aspheric constant was varied until the sphericalaberration value of the model cornea was equal to the average sphericalaberration value for the population. TABLE 12 The design cornea radiiand aspheric constants for aperture diameters of 4, 5, 6, and 7 mm.Aperture Conic Constant size (mm) Radius (mm) (OSLO value, K² − 1) Z11Coefficient (mm) 4 7.563 −0.0505 0.000139 5 7.553 −0.1034 0.000312 67.575 −0.14135 0.000604 7 7.55 −0.1810 0.001058

As discussed previously, the 6 mm aperture diameter values are used forthe design cornea. This choice enables us to design the Z11 lens so thatit has no spherical aberration (when measured in a system with thiscornea) over a 5.1 mm lens diameter. The OSLO surface listing for theZ11 design cornea is listed in Table 13. The refractive index of thecornea is the keratometry index of 1.3375.

These values were calculated for a model cornea having a single surfacewith a refractive index of the cornea of 1.3375. It is possible to useoptically equivalent model formats of the cornea without departing fromthe scope of the invention. For example multiple surface corneas orcorneas with different refractive indices could be used. TABLE 13 OSLOsurface listing for the Z11 design cornea. Aperture Conic Surface RadiusThickness Radius Constant Refractive # (mm) (mm) (mm) (cc) index Object— 1.0000e+20 1.0000e+14 — 1.0 1 7.575000 3.600000 3.000003 −0.1413501.3375 (cornea) 2 — — 2.640233 — 1.3375 (pupil) 3 — 0.900000 2.64023 —1.3375 4 25.519444 2.550292 — 1.3375 5 2.2444e−05 — 1.3375Lens Design:

Each Z11 lens was designed to balance the spherical aberration of thedesign cornea. The starting point for design was the CeeOn Edge© 911lens described in U.S. Pat. No. 5,444,106 of the same power, withmodified edge and center thickness. The lens was then placed 4.5 mm fromthe anterior corneal surface. The distance from the anterior cornealsurface is not that critical and could be varied within reasonablelimits. The surface information for the starting point eye model for the22 D lens design process is listed in Table 14. The anterior surface ofthe lens was described using the formula shown in Equation 4. Thevariables cc, ad and ae were modified to minimize the sphericalaberration. The variables are determined for an aperture size of 5.1 mmand the surface is extrapolated from these values to the opticalaperture size of 6 mm. The resulting 22D Z11 eye model is listed inTable 15. The anterior surface of this 22D lens has been modified insuch a way that the spherical aberration of the system (cornea+lens) isnow approximately equal to 0. The wavefront aberration coefficients ascalculated by OSLO for the CeeOn Edge 911 22D lens eye model and the 22DZ11 lens eye model are listed below in Table 16. Note that thecoefficient representing spherical aberration for the starting point eyemodel is 0.001005 mm for a 6 mm diameter aperture placed at the cornea,while the same coefficient for the eye model with the designed Z11 lensis −1.3399e-06 mm. The same process as described above for a 22D lenscan similarly be performed for any other lens power. $\begin{matrix}{z = {\frac{( {1/R} )r^{2}}{1 + \sqrt{1 - {( \frac{1}{R} )^{2}( {{cc} + 1} )r^{2}}}} + {adr}^{4} + {aer}^{6}}} & (4)\end{matrix}$ TABLE 14 Surface data for the starting point averaged eyemodel and a 22D lens Aperture Conic Radius Thickness Radius ConstantRefractive Surface # (mm) (mm) (mm) (cc) index Object — 1.0000e+201.0000e+14 — 1.0 1 (cornea) 7.575 3.600000 3.000003 −0.14135 1.3375 2(pupil) — — 2.640233 — 1.336 3 — 0.900000 2.64023 — 1.336 4 (lens)11.043 1.164 2.550191 — 1.458 5 (lens) −11.043 17.1512 2.420989 — 1.3366 (image) 0.0 −0.417847 0.058997 — —

TABLE 15 Surface data for the averaged eye model and the final 22D Z11lens Aperture Conic 4^(th) Order 6th Order Radius Thickness RadiusConstant aspheric aspheric Refractive Surface # (mm) (mm) (mm) (cc)Constant constant index Object — 1.0e+20 1.00e+14 — 1.0 1 7.575 3.603.00 −0.14135 1.3375 (cornea) 2 — — 2.64 — 1.336 (pupil) 3 — 0.90 2.64 —1.336 4 (lens) 11.043 1.164 2.55 −1.03613 −0.000944 −1.37e−05 1.458 5(lens) −11.043 17.1512 2.42 — 1.336 6 (image) — — 1.59e−05 — — — —

TABLE 16 Zernike coefficients (OSLO format) for the average cornea and a22D 911 lens and the average cornea and the 22D Z11 lens CoefficientAverage cornea + 22D 911 Average cornea + 22D Z11 a1 −0.000962 −1.896e−06 a2 0.0 0.0 a3 0.0 0.0 a4 2.3101e−05 −3.9504e−06 a5 0.0 0.0a6 0.0 0.0 a7 0.0 0.0 a8 0.0 0.0 a9 0.00105 −1.3399e−06 a10 0.0 0.0 a110.0 0.0 a12 0.0 0.0 a13 0.0 0.0 a14 0.0 0.0 a15 0.0 0.0

The optical form chosen for the new Z11 design is an equiconvex lensmade from a silicone with refractive index of 1.458. The sphericalaberration of an average cornea is balanced by the Z11lens yielding asystem without spherical aberration. The front surface of the lens ismodified such that the optical path lengths of all on-axis rays withinthe design aperture are the same producing a point focus. This featurecan be achieved with many lens forms. The Z11 lens could therefore bedesigned on a convex-plano, plano-convex, non-equiconvex lens or anyother design yielding a positive lens. The Z11 concept could also beextended in order to encompass a negative lens used to correct therefractive errors of the eye. The front surface or back surface couldalso be modified to produce the needed change in optical path differencethat neutralizes the spherical aberration. There are therefore manypossible designs that would achieve the goals of the Z11 lens design.

1. An ophthalmic lens, comprising: an aspheric surface; and anaberration term based on a lens design in which the aberration term isopposite in sign of, and is capable of compensating for, an averageaberration term of a corneal model based on a suitable population; thesuitable population being a group of people who will undergo an ocularsurgical procedure.
 2. The ophthalmic lens of claim 1, wherein theocular surgical procedure is a refractive corrective surgery.
 3. Theophthalmic lens of claim 1, wherein the ocular surgical procedure is acataract surgery.
 4. The ophthalmic lens of claim 1, wherein the ocularsurgical procedure is the implantation of an IOL.
 5. The ophthalmic lensof claim 1, wherein the ocular surgical procedure is the implantation ofa corneal inlay.
 6. The ophthalmic lens of claim 1, wherein the ocularsurgical procedure is a refractive corrective surgery.
 7. An ophthalmiclens, comprising: an aspheric surface; and an aberration term based on alens design in which the aberration term is opposite in sign of, and iscapable of compensating for, an average aberration term of a cornealmodel based on a suitable population; the suitable population being agroup of people who have undergone corneal surgery.
 8. The ophthalmiclens of claim 7, wherein the corneal surgery is laser in situkeratomileusis.
 9. The ophthalmic lens of claim 7, wherein the cornealsurgery is radial keratotomy.
 10. The ophthalmic lens of claim 7,wherein the corneal surgery is photorefractive keratotomy.
 11. Anophthalmic lens, comprising: an aspheric surface; and an aberration termbased on a lens design in which the aberration term is opposite in signof, and is capable of compensating for, an average aberration term of acorneal model based on a suitable population; the suitable populationbeing a group of people belonging to a specific age group.
 12. Anophthalmic lens, comprising an aspheric surface having a design thatincludes an aberration term that is opposite in sign of, and is capableof compensating for, an average aberration term of a corneal model basedon a suitable population.
 13. The ophthalmic lens of claims 12, whereinthe suitable population is a group of people who will undergo an ocularsurgical procedure.
 14. The ophthalmic lens of claims 12, wherein thesuitable population is a group of people who have undergone cornealsurgery.
 15. The ophthalmic lens of claims 12, wherein the suitablepopulation is a group of people belonging to a specific age group. 16.The ophthalmic lens of claims 12, wherein a wavefront arriving from anoptical system comprising the model cornea and the lens design obtains asubstantially reduced aberration compared to a similar lens design thatdoes not include the aberration term.